SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)
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Why opioid dependence needs treatment

Opioid dependence—addiction to prescription painkillers and heroin—is a treatable medical condition caused by changes in the chemistry of the brain.* When you're opioid dependent, the need to satisfy cravings or avoid withdrawal symptoms can be intense and difficult to manage on your own.

By suppressing withdrawal symptoms and reducing cravings, SUBOXONE Film can help people with opioid dependence take steps to manage their condition so they can focus on rebuilding their lives.

Managing a long-term medical condition takes time

Managing opioid dependence is not simply a matter of "getting clean" or stopping all drug use. Typically, the changes that cause opioid dependence will not be corrected right away. In fact, those changes can trigger cravings months or even years after you've stopped misusing opioids. That's why ongoing treatment that includes counseling and behavioral therapy is so important.

Many long-term medical conditions—not only opioid dependence but also diabetes, high blood pressure, and asthma—are treated with both medication and changes to behavior. Since these conditions are ongoing, the treatments are, too. SUBOXONE Film, a proven medication-assisted treatment, is meant to help you keep your symptoms under control so you can focus on the changes you and your treatment team decide you need to make.

*Both the World Health Organization (WHO) and the National Institute on Drug Abuse (NIDA) have defined dependence on opioids as “a long-term brain disease.”

Frequently asked questions about treatment:

Q: What is opioid dependence (also called addiction)?

Dependence on opioids—opioid prescription pain medication or heroin—is a treatable medical condition caused by changes in the chemistry of the brain that occur as a result of the use of opioids. It has been defined as a long-term brain disease by both the World Health Organization and the National Institute on Drug Abuse.

Opioid dependence can begin with a simple prescription to treat serious pain or with the recreational drug use of prescription pain medications or heroin. Regardless of how a person becomes dependent, once dependence has developed it is considered a long-term medical condition that requires treatment.

Q: Why is opioid dependence a long-term (chronic) condition?

The development of opioid dependence causes complex, long-term, changes in the structure and functioning of the brain. The significant changes to brain "circuitry" have led addiction, medical, and scientific experts to classify it as a disease that interferes with normal brain functioning.

Typically, the changes that cause opioid dependence will not correct themselves right away, even though the misuse of opioids has stopped. In fact, these changes can trigger cravings months and even years after someone has stopped using opioids. Consequently, managing opioid dependence is not simply a matter of eliminating drugs from the body.

Q: Why can't I stop misusing opioids on my own?

The initial decision to take a drug, whether a prescribed medication or a "street" drug, would be considered under voluntary control. However, when someone develops a dependence on that substance, the person's ability to exert self-control can become seriously compromised. Brain imaging studies from drug-dependent individuals show physical changes in areas of the brain that are critical to judgment, decision-making, learning and memory, and behavior control. Scientists believe that these changes alter the way the brain works, and may help explain the compulsive and destructive behaviors of drug dependence.

Although, logically, a person may know that opioids are not essential for life, as long as those parts of the brain in charge of survival behavior still believe opioids are necessary, they may override "higher reasoning." Furthermore, to an opioid-dependent brain, not having enough opioids to satisfy cravings or suppress withdrawal is comparable to not having enough food to satisfy hunger.

The need to obtain opioids can become more important than that person's safety because opioid-dependence can impair the mechanism by which information from certain areas of the brain—namely, those involved with judgment and caution—is received. The brain responds by taking whatever steps are necessary to see that its opioid "hunger" is met, which usually means pursuing opioids with all the drive of a basic instinct.

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Important Safety Information

Indication

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of healthcare providers qualified under the Drug Addiction Treatment Act.

Important Safety Information

Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Film contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about the difference between physical dependence and drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Film.

You should not drink alcohol while taking SUBOXONE Film, as this can lead to loss of consciousness or even death.

Death has been reported in those who are not opioid dependent.

Your healthcare provider may monitor liver function before and during treatment.

SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting the SUBOXONE Film product may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Before taking SUBOXONE Film, tell your healthcare provider if you are pregnant or plan to become pregnant. If you are pregnant, tell your healthcare provider as withdrawal signs and symptoms should be monitored closely and the dose adjusted as necessary. If you are pregnant or become pregnant while taking SUBOXONE Film, alert your healthcare provider immediately and you should report it using the contact information provided below. *

Opioid‐dependent women on buprenorphine maintenance therapy may require additional analgesia during labor.

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly.

Before taking SUBOXONE Film, talk to your healthcare provider if you are breastfeeding or plan to breastfeed your baby. The active ingredients of SUBOXONE Film can pass into your breast milk. You and your healthcare provider should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Film affects you. Buprenorphine in SUBOXONE Film can cause drowsiness and slow reaction times during dose-adjustment periods.

Common side effects of SUBOXONE Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

This is not a complete list of potential adverse events associated with SUBOXONE Film. Please see full Prescribing Information for a complete list.

*To report pregnancy or side effects associated with taking SUBOXONE Film, please call 1-877-782-6966. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information about SUBOXONE Film, SUBOXONE® (buprenorphine and naloxone) Sublingual Tablets (CIII), or SUBUTEX® (buprenorphine) Sublingual Tablets (CIII), please see the respective full Prescribing Information and Medication Guide at www.suboxoneREMS.com.

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IMPORTANT SAFETY INFORMATION AND INDICATION

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.